Label: PAIN RELIEVER PLUS SLEEP AID NIGHTTIME- acetaminophen, diphenhydramine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredients (in each 30 mL)

    Acetaminophen 1,000 mg
    Diphenhydramine HCl 50 mg

  • Purpose

    Pain reliever
    Nighttime sleep-aid

  • Use

    for the temporary relief of occasional minor aches and pains with accompanying sleeplessness

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • drowsiness will occur
    • avoid alcoholic beverages
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • mL = milliliter
    • only use the dose cup provided
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: 30 mL at bedtime
    • children under 12 years: do not use
  • Other information

    • each 30 mL contains: sodium 12 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol,
    sucralose, xanthan gum

  • Questions or comments?

    Call 1-800-632-6900

  • Principal Display Panel - Kroger

    NDC 30142-093-02

    Kroger® Health

    COMPARE TO THE ACTIVE
    INGREDIENTS INVICKS®
    ZZZQUIL® NIGHT PAIN LIQUID*

    MAXIMUM STRENGTH

    NightTime
    Pain Reliever +
    Sleep Aid

    Acetaminophen
    Diphenhydramine HCl
    PAIN RELIEVER/
    NIGHTTIME
    SLEEP-AID
    NON-HABIT FORMING

    12 YEARS
    AGES
    and OVER

    F-074 ORG

    MIDNIGHT-BERRY
    FLAVOR

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by The Procter &
    Gamble Company. VICKS® and ZzzQuil® are registered trademarks of
    The Procter & Gamble Company. 50844 ORG052307402

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
    For More Product Information, Scan UPC Using Your
    Kroger App or Call 800-632-6900
    ‡OUR PHARMACIST
    RECOMMENDED
    Our Brands. Our Guarantee.
    Love It or Your Money Back.
    www.kroger.com

    kroger 44-074

    kroger 44-074

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PLUS SLEEP AID  NIGHTTIME
    acetaminophen, diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-093
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorpurple (Dark) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-093-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/22/2024
    Labeler - Kroger Company (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(30142-093) , pack(30142-093)
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